510(k) K220305
- Device
- Syntheon LAA Exclusion System, Syntheon LAA Selection Guide
- Applicant
- Syntheon
- 510(k) number
- K220305
- Product code
- PZX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-10-28
- Date received
- 2022-02-02
- Regulation
- 878.4300
- Classification name
- Left Atrial Appendage Clip, Implantable
- Medical specialty
- General & Plastic Surgery
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Sean McBryer
- Address
- 13755 SW 119 Ave. Miami FL US 33186 33186
FDA Registration Numbers#
- 1424263
- 2184009
- 3011706110
- 1450662
- 3003139373
- 1526711
- 1649518
Source Documents#
Other 510(k) Records For Product Code PZX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252917 | ATLAAS (Atraumatic Left Atrial Appendage System) (AD) | Genesee Biomedical, Inc. | 2026-05-22 |
| K243860 | AtriClip PRO-Mini LAA Exclusion System (PROM) | AtriCure, Inc. | 2025-01-15 |
| K234125 | AtriClip FLEX-Mini LAA Exclusion System (ACHM) | AtriCure, Inc. | 2024-07-29 |
| K233407 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH2); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2); AtriClip PRO-V LAA Exclusion System (PROV); AtriClip Flex-V LAA Exclusion System with preloaded V Clip (ACHV) | AtriCure, Inc. | 2023-11-02 |
| K232295 | LAA Exclusion System | Syntheon, LLC | 2023-08-30 |
| K210293 | AtriClip LAA Exclusion System | AtriCure, Inc. | 2021-03-03 |
| K191413 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-Clip | AtriCure, Inc. | 2019-08-21 |
| K181474 | ArtiClip LAA Exclusion System | AtriCure, Inc. | 2018-06-28 |
Legacy Summary#
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FDA Review#
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